Device |
self-contained blood grouping |
Definition |
Intended for single use for individual blood group determination for educational and informational purposes |
Physical State |
Plastic card with mixing channels and monoclonal antibodies |
Technical Method |
The device is self-contained and consists of reagents and reaction areas and requires no other accessories with the exception of those used to add the blood sample to the device |
Target Area |
Plastic/paper card, plate, slide or microtubules with blood grouping antibodies |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | OQX |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.9175
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |